Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:02 AM
Study NCT ID:
NCT07370220
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012431', 'term': 'Rutin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate of Clinical Improvement', 'timeFrame': 'Day 30 (End of treatment)', 'description': 'The percentage of participants who achieve clinical improvement at the end of the treatment period. Clinical improvement is defined as reaching a score of 5 or less on the Simple Clinical Colitis Activity Index (SCCAI).'}], 'secondaryOutcomes': [{'measure': 'Change in Fecal Calprotectin Levels', 'timeFrame': 'Baseline and Day 30', 'description': 'The concentration of Fecal Calprotectin measured in stool samples to quantify the reduction in intestinal inflammation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This study evaluates the therapeutic role of Rutin (a plant-derived flavonoid) in reducing the severity of Ulcerative Colitis (UC). The study investigates whether Rutin can decrease intestinal inflammation and improve clinical symptoms by inhibiting the NLRP3 inflammasome signaling pathway, which is activated by oxidative stress in the colon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of UC confirmed by endoscopy/histology.\n* Age 18 to 65 years.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to Rutin.\n* Presence of other serious systemic diseases (e.g., malignancy, severe hepatic or renal failure).'}, 'identificationModule': {'nctId': 'NCT07370220', 'briefTitle': 'Effect of Rutin on Inflammation Pathways in Ulcerative Colitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Rutin Therapy Reduces Ulcerative Colitis Disease Activity By Inhibiting The NOD-Like Receptor Protein 3 (NLRP3) Inflammasome: A Molecular Assessment in an Interventional Study.', 'orgStudyIdInfo': {'id': 'Rc 3.1.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Ulcerative Colitis (UC-A)', 'interventionNames': ['Drug: Rutin 500 MG Oral Tablet', 'Diagnostic Test: Fecal Calprotectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remission Ulcerative Colitis (UC-B)', 'interventionNames': ['Diagnostic Test: Fecal Calprotectin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy Control (Group C)', 'interventionNames': ['Diagnostic Test: Fecal Calprotectin']}], 'interventions': [{'name': 'Rutin 500 MG Oral Tablet', 'type': 'DRUG', 'description': 'Oral capsules twice daily for 30 days', 'armGroupLabels': ['Active Ulcerative Colitis (UC-A)']}, {'name': 'Fecal Calprotectin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sample collection only for baseline comparison.', 'armGroupLabels': ['Active Ulcerative Colitis (UC-A)', 'Healthy Control (Group C)', 'Remission Ulcerative Colitis (UC-B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets for 30 days', 'armGroupLabels': ['Remission Ulcerative Colitis (UC-B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Al Qalyoubia', 'country': 'Egypt', 'facility': 'Benha Faculty of Medicine', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant consultant of Clinical Pathology', 'investigatorFullName': 'Raafat R. Mohammed', 'investigatorAffiliation': 'Benha University'}}}}